- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07741643
Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
Phase I Open-Label Study Evaluating the Safety and Feasibility of Panitumumab-IRDye800 and [18F]NOTA-ABY-030 for Targeted Dual-Modality Imaging (TDMI) in Head and Neck Squamous Cell Carcinoma
The goal of this clinical trial is to learn whether using two imaging agents-Panitumumab-IRDye800 (Pan800) and[18F]NOTA-ABY-030-is safe and feasible for helping surgeons identify tumors and cancer-containing lymph nodes during surgery in adults with head and neck squamous cell carcinoma (HNSCC) who are scheduled for tumor removal and neck dissection.
The main questions it aims to answer are:
- Is the combination of Pan800 and [18F]NOTA-ABY-030 safe and well tolerated in patients undergoing surgery for HNSCC?
- How accurately can Pan800 and [18F]NOTA-ABY-030 detect tumor tissue and cancer-positive lymph nodes when compared with final pathology results?
This is a single-arm, open-label study, so there is no comparison group.
Study Related Steps:
- Receive an intravenous infusion of Pan800 1-2 days before surgery.
- Receive an intravenous injection of[18F]NOTA-ABY-030 on the day of surgery.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Makenna Brown
- Telefonnummer: 6154214370
- E-post: makenna.l.brown@vumc.org
Studer Kontakt Backup
- Navn: Nicole Jones
- E-post: nicole.l.jones@vumc.org
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years.
- Subjects diagnosed with any T stage or N stage squamous cell carcinoma and any subsite within the head and neck that are scheduled to undergo surgical resection and neck dissection. Subjects with recurrent disease or a new primary will be allowed.
Have acceptable hematologic status, kidney function, and liver function including the following clinical results:
- Hemoglobin ≥ 9 gm/dL
- White blood cell count > 3000/mm3
- Platelet count ≥ 100,000/mm3
- Serum creatinine ≤ 1.5 times upper reference range
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment.
- Evidence of QTcF prolongation on ECG within 30 days of pan800 administration (greater than 480 ms).
- History of infusion reactions to monoclonal antibody therapies.
- History of allergies to iodine.
- Pregnant or breastfeeding.
- Magnesium or phosphorus lower than the normal institutional values and the patient is symptomatic.
- Subjects receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents.
- Subjects with history or evidence of interstitial pneumonitis or pulmonary fibrosis.
- Severe renal disease or anuria.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 5.0 mCi - [18F]NOTA-ABY-030 and 50 mg - pan800
|
IV Infusion of 50 mg dose of Panitumumab-IRDye800 (Pan800) 1-2 days before surgery.
Single intravenous bolus injection of approximately 5 mCi (±10%) in the operating room prior to tumor removal and neck dissection.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Record and evaluate the number events considered clinically significant Grade ≥2 AEs that are considered possibly, probably, or definitely related to [¹⁸F]NOTA-ABY-030, pan800, or both agents.
Tidsramme: Up to 30 Days
|
Up to 30 Days
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Sykdommer i luftveiene
- Neoplasmer etter histologisk type
- Neoplasmer, kjertel og epitel
- Karsinom
- Neoplasmer, plateepitelceller
- Otorhinolaryngologiske sykdommer
- Plateepitelkarsinom i hode og nakke
- Karsinom, plateepitel
- Neoplasmer i hode og nakke
- Laryngeale sykdommer
Andre studie-ID-numre
- VICCHNP26039
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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